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FDA approval
FDA approves Apple Watch sleep apnea detection feature
Digital Wellness
Sep 16, 2024
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Digital Wellness

Digital Wellness

Sep 16, 2024

FDA approves Apple Watch sleep apnea detection feature

FDA approval

  • The US Food and Drug Administration (FDA) has approved sleep apnea detection for the Apple Watch Series 9, Series 10, and Watch Ultra 2.

  • The feature requires 10 nights of sleep tracking data over 30 days to assess the risk of sleep apnea. It will be available in the upcoming watchOS 11 release.

  • The FDA classifies this as an "over-the-counter device to assess risk of sleep apnea." Apple emphasizes that it is not a diagnostic tool but will prompt users to seek formal diagnoses from healthcare providers.

  • Analyst QuickTake: Earlier this month , Apple also received FDA approval for a software update that allows Apple's AirPods Pro 2 to function as over-the-counter hearing aids. With today’s FDA’s approval, Apple has taken another step toward its devices functioning in healthcare roles beyond traditional wearable technology capabilities.

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